Table 3 Toxicity by patient and by cycle NCI/CTC
By patient | By cycle | |||||
|---|---|---|---|---|---|---|
Adverse events by NCI/CTC | Overall incidence N (%) | Grade 3 N (%) | Grade 4 N (%) | Overall incidence N (%) | Grade 3 N (%) | Grade 4 N (%) |
Neutropenia | 43 (87.8) | 8 (16.3) | 24 (49.0) | 130 (50.4) | 27 (10.5) | 48 (18.6) |
Leucopenia | 44 (89.8) | 15 (30.6) | 12 (24.5) | 159 (61.6) | 44 (17.1) | 15 (5.8) |
Anaemia | 48 (98.0) | 5 (10.2) | 1 (2.0) | 224 (86.8) | 7 (2.7) | 1 (0.4) |
Thrombocytopenia | 26 (53.1) | 1 (2.0) | 2 (4.1) | 58 (22.5) | 5 (1.9) | 2 (0.8) |
Infection | ||||||
Neutropenic inf. | 6 (12.2) | 6 (12.2) | ’ | 6 (2.3) | 6 (2.3) | ’ |
Inf. without neutropenia | 13 (26.5) | ’ | ’ | 28 (10.8) | ’ | ’ |
Inf. other | 1 (2.0) | ’ | ’ | 1 (0.4) | ’ | ’ |
Catheter inf. | 1 (2.0) | 1 (2.0) | ’ | 1 (0.4) | 1 (0.4) | ’ |
Gastrointestinal | ||||||
Nausea | 42 (85.7) | 1 (2.0) | ’ | 124 (47.9) | 1 (0.4) | ’ |
Vomiting | 29 (59.2) | 2 (4.1) | 1 (2.0) | 56 (21.6) | 2 (0.8) | 1 (0.4) |
Diarrhoea | 26 (53.1) | 1 (2.0) | ’ | 53 (20.5) | 1 (0.4) | ’ |
Dysphagia | 11 (22.5) | ’ | ’ | 7 (2.7) | ’ | ’ |
Anorexia | 5 (10.2) | ’ | ’ | 83 (32.1) | 6 (2.3) | ’ |
Stomatitis | 31 (63.3) | 5 (10.2) | ’ | 18 (7.0) | 1 (0.4) | ’ |
Constipation | 9 (18.4) | 1 (2.0) | ’ | 23 (8.9) | 1 (0.4) | ’ |
Dyspepsia | 9 (18.4) | 1 (2.0) | ’ | 11 (4.3) | ’ | ’ |
Mouth dryness | 7 (14.3) | ’ | ’ | 124 (47.9) | 1 (0.4) | ’ |
Dermatology | ||||||
Alopecia | 45 (91.8) | ’ | ’ | NA | NA | NA |
Injection site reaction | 19 (38.8) | 1 (2.0) | ’ | 39 (15.1) | 1 (0.4) | ’ |
Cardiovascular | ||||||
Phlebitis | 1 (2.0) | ’ | ’ | 1 (0.4) | 1 (0.4) | ’ |
Arrhythmia | 1 (2.0) | 1 (2.0) | ’ | 1 (0.4) | 1 (0.4) | ’ |
Neurological | ||||||
Dizziness | 6 (12.2) | ’ | ’ | 9 (3.5) | ’ | ’ |
Neurosensory | 9 (18.4) | ’ | ’ | 21 (8.1) | ’ | ’ |
Vertigo | 5 (10.2) | ’ | ’ | 9 (3.5) | ’ | ’ |
Constitutional | ||||||
Fatigue | 38 (77.6) | 3 (6.1) | ’ | 140 (54.1) | 6 (2.3) | ’ |
Fever in the absence of neutropenia | 7 (14.3) | ’ | ’ | 7 (2.7) | ’ | ’ |
Pain | ||||||
Abdominal | 10 (20.4) | ’ | ’ | 16 (6.2) | ’ | ’ |
Arthralgia | 6 (12.2) | 2 (4.1) | ’ | 16 (6.2) | 2 (0.8) | ’ |
Headache | 9 (18.4) | 1 (2.0) | ’ | 21 (8.1) | 1 (0.4) | ’ |
Myalgia | 8 (16.3) | ’ | ’ | 19 (7.3) | ’ | ’ |
Pain other | 6 (12.2) | ’ | ’ | 13 (5.0) | ’ | ’ |
